Adaptive Infant Positioning

ABSTRACT

Systems, methods and instrumentalities are disclosed for adaptive infant positioning to reliably maintain an infant of any size in any position. An infant positioning device may comprise, for example, one or more barrier restraints and infant restraints with or without accessory restraints. A barrier may form-fit an infant in any position (e.g. without gap fillers). A barrier restraint may resist barrier movement, e.g., by underlaying an infant and overlaying and tucking under a barrier. An infant restraint may resist infant movement, e.g., by overlaying an infant and tucking under a barrier. An accessory restraint may restrain accessories, e.g., for substrate adaptation, height adjustment, position-sculpting, comfort pads or devices and/or medical devices. Adaptive infant positioning may reliably maintain infants in proper developmental positions, reduce repositioning corrections, simplify positioning and repositioning procedures, reduce positioning errors, reduce handling and aural disruptions, reduce supplemental devices and procedures and/or reduce inventory space and costs.

BACKGROUND

A womb provides a fetus with a healthy developmental environment, such as protection from over-stimulation, midline positioning, flexion and physical boundaries that provide resistance and feedback to movement (e.g. when a fetus kicks a uterus). A womb may, for example, help a fetus form neuro connections that reinforce flexion and midline posture as a normal baseline. A fetus born prematurely (a premature infant or “preemie”) is exposed to an environment that it may be neurologically and/or physically unprepared for. For example, a preemie may be exposed to forces, movements, lights and sounds that may be overstimulating or may interfere with proper development of an underdeveloped brain, bones and/or muscles. Exposure may be extensive, for example, when preemies are long-term patients in Hospital Neonatal Intensive Care Units (NICUs).

SUMMARY

This Summary is provided to introduce concepts in a simplified form. These concepts are described in greater detail below in the sections entitled Detailed Description, Brief Description of the Drawings, Claims, and in the figures. This Summary is not intended to identify key or essential features of the described or claimed subject matter, nor limit the scope thereof.

Systems, methods and instrumentalities are disclosed for adaptive infant positioning to reliably maintain an infant of any size in any position. An infant positioning device may comprise, for example, one or more barrier restraints and infant restraints with or without accessory restraints. A barrier may form-fit an infant in any position (e.g. without gap fillers). A barrier restraint may resist barrier movement, e.g., by underlaying an infant and overlaying and tucking under a barrier. An infant restraint may resist infant movement, e.g., by overlaying an infant and tucking under a barrier. An accessory restraint may restrain accessories, e.g., for substrate adaptation, height adjustment, position-sculpting, comfort pads or devices and/or medical devices. Adaptive infant positioning may reliably maintain infants in proper developmental positions, reduce repositioning corrections, simplify positioning and repositioning procedures, reduce positioning errors, reduce handling and aural disruptions, reduce supplemental devices and procedures and/or reduce inventory space and costs.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings, summary, detailed description and claims individually and collectively present non-limiting examples. Unless indicated otherwise, each figure represents a different example with different numbering.

FIG. 1A is a top view of an example of an infant positioning device.

FIG. 1B is a bottom view of an example of an infant positioning device.

FIG. 1C is a side view of an example of an infant positioning device.

FIG. 2A is an example of a formable barrier that may be restrained by an infant positioning device.

FIG. 2B is an example of a formable barrier that may be restrained by an infant positioning device.

FIG. 3A is an example of a positioning device and an infant barrier.

FIG. 3B is an example of a positioning device restraining an infant barrier and an infant.

FIG. 3C shows a side view of an example of a positioning device restraining a barrier and an infant.

FIG. 4A is an example of a positioning device and an infant barrier, an accessory and an infant to be restrained by the positioning device.

FIG. 4B is a bottom view of an example of a positioning device restraining a barrier, an accessory and an infant.

FIG. 5A is a cross section view of an example of a positioning device restraining a barrier and an infant.

FIG. 5B is a cross section view of an example of a positioning device restraining a barrier and an infant.

FIG. 6 is an example of an infant positioning procedure.

DETAILED DESCRIPTION

A detailed description of illustrative embodiments will now be described with reference to the various Figures. Although this description provides examples of possible implementations, it should be noted that details provided in examples are intended to be exemplary and in no way limit the scope of the application. The present technology may be practiced without these specific details. The present technology is intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope the various embodiments as defined herein, including by the appended claims. In addition, in the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present technology. However, the present technology may be practiced without these specific details. In other instances, well known methods, procedures, components, and circuits have not been described in detail as not to unnecessarily obscure aspects of the embodiments presented.

References in the specification to “embodiment,” “example embodiment,” or the like, indicate that the embodiment described may include a particular feature, structure, characteristic or step, but every embodiment may not necessarily include the particular feature, structure, characteristic or step. Moreover, such phrases are not necessarily referring to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to implement such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.

Certain terms are used throughout the following description and claims to refer to particular system components and configurations. As one skilled in the art will appreciate, various skilled artisans and companies may refer to a component by different names. The discussion of embodiments is not intended to distinguish between components that differ in name but not function. In the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . .” Also, the term “attached” is intended to mean either an indirect or direct connection. The terms maintain and substantially maintain are used interchangeably to have the same meaning of constant+/−10% variation.

Infant positioning devices and/or procedures (referred to as “positioning” or “repositioning”) may (e.g. substantially) improve long term outcomes for fragile premature infants (e.g. by supporting one or more developmental goals). Positioning may mimic one or more protective functions of a womb. Positioning may occur at periodic and/or aperiodic intervals. Positioning may, for example, promote proper development of bones and muscles, decrease stress, encourage physiologic stability, decrease oxygen needs, decrease accidental extubations (e.g. from agitation), encourage closure of ductus arteriosus (e.g. from reduced crying), reduce some risk factors for intraventricular hemorrhage (e.g. stress and non-midline positions), improve neurobehavioral organization and/or ability to interact with an environment, improve feeding performance, promote sleep, improve brain development and/or encourage weight gain.

Positioning may provide, for example, minimal stimulation, minimal handling and containment around an infant. Positioning may promote (e.g. consistent) midline posture with (e.g. full) flexion of arms and legs while allowing one or more types of movement (e.g. kicking) and (e.g. adequate) resistance for subsequent recoil. An infant may be supported (e.g. in supine, prone, side lying and semi-side lying positions), for example, in a (e.g. slightly) rounded and (e.g. fully) flexed position, e.g., where the back and shoulders may be prevented from retracting or arching. Support for semi sidelying (e.g. a degree of rotation between supine and sidelying positions may be useful, for example, to avoid scaphocephaly (skull flattening) and improve lung expansion of Extremely low birth weight (ELBW) infants who may not tolerate a sidelying position. A tucked, midline posture may be maintained with minimal handling of an infant, e.g., to accomplish changes in position. Positioning may provide visualization of an infant's chest and abdomen, for example, during “non-stim” assessments. Positioning may maintain (e.g. adequate) containment of an infant, for example, during “hands-on” assessments or procedures. Positioning devices may provide containment during admission. Positioning may adhere to newborn golden hour guidelines for proper positioning in the moments to days after premature birth.

Positioning devices and procedures may be evaluated or compared, for example, based on criteria such as their ability or inability to reliably support one or more developmental goals, mimic a womb, avoid disturbing an infant, support reliable infant containment, flexion of arms, flexion of legs, natural movement (e.g. kicking) and recoil while maintaining position, reliable maintenance of developmental positions (e.g. prone, supine, side-lying variations), support midline head position (e.g. including during admissions), log rolling, phototherapy, medical and biological procedures, insertion of peripherally inserted central catheter (PICC), umbilical catheters, peripherally intravenous line (PIVs), avoid disturbing an infant, support low cost, fast, simple and/or safe procedures to avoid errors and adverse outcomes. A positioning device and/or related procedure may, for example, fail to achieve containment (e.g. in one or more developmentally supportive positions), achieve containment with too much disruption of an infant or lose containment over time, which may result in an infant slumping out of a developmentally appropriate position. A positioning device and/or related procedure may, for example, fail to maintain a midline position of an infant's head between position changes (e.g. causing breathing problems or disruption). A positioning device and/or related procedure may, for example, require use of supplemental (e.g. extra or add-on) devices (e.g. tools) and/or procedures (e.g. stuffing items into gaps) to compensate for a lack of containment or other ineffectiveness or inefficiencies in devices and/or procedures, which may require more time, induce errors, result in unreliable positioning, be increasingly disruptive to infants and increase costs and inventory. A positioning device and/or related procedure may, for example, with or without supplemental devices and/or procedures, have or lead to additional costs, time, complexity, confusion, misuse, infant disruption and/or inability to support developmental goals. A positioning device and/or related procedure may, for example, lack (e.g. sufficient) adjustability or adaptation, which may mean (e.g. due to cost and inventory limitations) an infant may not fit an available size of a positioning device and may lead to ad hoc attempts to rectify deficiencies, such as filling gaps with blankets or cloths that may fall away over time. A positioning device and/or related procedure may, for example, fail to provide access to an infant (e.g. for repositioning, changing diapers) without significant disruption. For example, containment that is incorrectly sized with gap fillers may result in containment falling away from an active infant wriggling and/or kicking. Unreliable containment, in addition to causing additional unnecessary infant disruptions, defeats the purpose of snug containment intended to provide proper positioning to decrease stress, prevent dolichocephaly, maintain golden hour requirements and improve airway, among other benefits.

Systems, methods and instrumentalities are disclosed for adaptive infant positioning to reliably maintain an infant of any size in any position while satisfying (e.g. excelling in) one or more (e.g. all) performance criteria (e.g. as discussed herein). An infant positioning device may comprise, for example, one or more barrier restraints and infant restraints with or without accessory restraints. A barrier may form-fit an infant in any position (e.g. without gap fillers). A barrier restraint may resist barrier movement, e.g., by underlaying an infant and overlaying and tucking under a barrier. An infant restraint may resist infant movement, e.g., by overlaying an infant and tucking under a barrier. An accessory restraint may restrain accessories, e.g., for substrate adaptation, height adjustment, position-sculpting, comfort pads or devices and/or medical devices. Position-sculpting accessories may be used, for example, to arrange support for an infant in a position. Adaptive infant positioning may reliably maintain infants in proper developmental positions, reduce repositioning corrections, simplify positioning and repositioning procedures, reduce positioning errors, reduce handling and aural disruptions, reduce supplemental devices and procedures and/or reduce inventory space and costs.

FIG. 1A is a top view of an example of an infant positioning device. FIG. 1B is a bottom view of an example of an infant positioning device. FIG. 1C is a side view of an example of an infant positioning device.

An infant positioning device may serve multiple purposes. An infant positioning device may, for example, restrain one or more barriers, restrain one or more accessories (e.g. attachments or inserts such as adaptive comfort or position-sculpting pads) and restrain an infant, e.g., to reliably maintain any infant in any position with adaptable form-fitting positioning and restraint. In an example, infant restraints may comprise, for example, one or more upper body restraints (e.g. crisscross restraints), one or more lower body restraints and a head restraint. A positioning device may comprise, for example, a continuously or partially (e.g. discretely) pliable layer (e.g. sheet, blanket) configured for multiple types of restraint. A restraint may comprise, for example, a binding, wrap, strap, band, ligature, tie, portion, etc., which may be integrated or part of and/or permanently or temporarily affixed to a positioning device. One or more restraints may operate independently or cooperatively.

A positioning device may have or be constructed with one or more types or a variety of shapes, dimensions, weights, materials and flexibilities. Thickness of a positioning device may vary. In an example, a positioning device may be thicker in areas that may be under an infant and thinner in areas that may be used for restraining (e.g. at or near edges with or without thickness tapering). In an example, none or more portions of positioning device may stretch (e.g. in one or more directions) and none or more portions may not stretch. In an example, a positioning device may comprise one or more layers of one or more types of material (e.g. two-way stretch, four-way stretch). Material stretch direction(s) may vary, for example, depending on location. In an example, a two-way stretch material that stretches along the y-axis may be implemented for an infant lower body (e.g. leg) restraint and a two-way stretch material that stretches along the x-axis may be implemented for an infant upper body (e.g. arm) restraint, e.g., allowing stretch perpendicular to the direction of restraint. Force redirection away from restraint axis or axes may support reliable positioning and containment.

A positioning device may be implemented in a wide variety of sizes, shapes and materials. Sizes, shapes and materials may be selected, for example, to restrain one or more barrier types, one or more accessory types and one or more size ranges or types of infants (e.g. term, pre-term). Sizes, shapes and materials may, for example, be based on one or more (e.g. all) types of barriers (e.g. sizes, shapes and materials) that may be used with a positioning device. Sizes, shapes and materials may be selected, for example, based on a range of infant sizes (e.g. term, pre-term, small, medium, large) and positions that may be restrained. Sizes, shapes and materials may be selected, for example, based on one or more techniques that may be used to restrain barriers (e.g. overlaying and tucking under a barrier or attaching to a barrier) and techniques that may be used to restrain infants (e.g. overlaying an infant and tucking under a barrier). Sizes, shapes, materials and interaction of features may be selected to restrain, for example, by causing an infant, barrier and/or accessory to recoil back to position upon movement (e.g. allowing a degree of movement, but maintaining position by resistance and/or inducing recoil back to position).

Types of restraint for barriers and infants may be selected, for example, for effectiveness in reliably maintaining a position, for simplicity (e.g. to reduce time and avoid errors) and/or to minimize disruption of an infant, e.g., minimize physical handling, exposure to temperature changes, airflow, noise, etc. when positioning, repositioning, performing medical or other procedures, etc. One or more types of restraint may be implemented, including but not limited to, overlay and tuck (e.g. high friction material) under a barrier and/or attachment or fastening to a barrier, such as quiet Velcro, quiet snaps, embedded magnets, continuous or discrete cinches or clamps, feed-through loops or slits, clasps, etc. In an example, a barrier restraint may comprise a positioning device overlaid and tucked under the barrier. Tucking of the positioning device may comprise, for example, continuous tucking (e.g. to maximize points of contact and friction) and/or discrete tucking (e.g. tucking tabs extending from or attached to a positioning device). In an example, a high friction material for positioning device restraints may be coordinated with a barrier and/or substrate material under a barrier. In an example, high friction material may comprise high friction fabric or fabric coated with PVC.

Infant positioning device 17 may comprise, for example, first (e.g. upper) portion 1 and second (e.g. lower) portion 2. First and second portions 1, 2 may provide one or more restraints to restrain an infant, one or more barriers and zero or more accessories. Restraints may be dedicated (e.g. providing one type of restraint) or multi-purpose/multi-use (e.g. providing multiple types of restraint, such as restraining a combination of one or more barriers, an infant and/or one or more accessories). First portion 1 may comprise one or more restraints, such as, for example, first and second infant (e.g. upper body) restraints 3, 4, third infant (e.g. head) restraint 22, first, second and third barrier restraints 24, 25, 26, first, second, third and fourth accessory restraints 29, 30, 31 and 32. One or more restraints may, for example, begin at a location below or under an infant. One or more restraints may, for example, wrap over and across the infant.

In an example, first and second portions 1 and 2 of positioning device 17 may comprise, for example, one type of material (e.g. stretchable knit or blend cotton) that stretches in the y-axis and may or may not stretch in the x-axis. First and second infant restraints 3, 4 may stretch in the x-axis and may or may not stretch in the y-axis. In an example, first and second portions 1 and 2 of positioning device 17 may comprise, for example, two types of material. In an example, first portion 1 may comprise non-stretchable material (e.g. woven cotton) and second portion 2 may comprise stretchable material (e.g. knit cotton or cotton blend) that stretches in the y-axis and may or may not stretch in the x-axis. First and second infant restraints 3, 4 may comprise stretchable material that may stretch in the x-axis and may or may not stretch in the y-axis.

First and second infant restraints 3, 4 may, for example, be continuous with first portion 1, attached (e.g. stitched) to first portion 1, detachable or otherwise removable from first portion 1. Attachment(s) that may come in contact with an infant may be, for example, relatively smooth (e.g. to avoid discomfort). Attachments may or may not be positioned to avoid contact with infants. Restraints (e.g. combined with barriers) may provide circumferential restraint or containment of an infant. In an example, first and second infant restraints 3, 4 may comprise one or more straps or flaps stitched to positioning device 17. Attachment spacing may be, for example, equidistant from a center of positioning device 17. In an example, first and second infant restraints 3, 4 may comprise a removable strap that feeds through one or more openings (e.g. slit(s)) in first portion 1. Multiple restraints may be joined together. In an example, second restraint 4 may comprise an opening (e.g. slit) 5 to feed first restraint 3 through, permitting first and second infant restraints 3, 4 to be (e.g. temporarily) joined together for independent and combined operation. In an example, material around opening 5 may be reinforced. Reinforcing material 35 may, for example, reinforce opening 5 in second infant restraint 4. Infant restraints may have any shape. In an example, first and second infant restraints 3, 4 may angle and/or taper, being wider near an infant's shoulders and narrower at an opposing end near a restraint. Tapering may, for example, contain shoulders and upper arms without covering an infant's face or abdomen. Tapering may be, for example, straight, angled and/or curved. Restraints may leave a portion of an infant's chest visible to assess respiratory effort. A width of first and second infant restraints at an attachment point may be, for example, wide enough to cover from a shoulder to an elbow of an average term or preterm infant. As previously indicated, although the example in FIG. 1 shows two upper body restraints, other implementations may have fewer, the same or more upper body restraints.

In an example, a broadest portion of first and second infant restraints 3, 4 where they join first portion 1 may be, for example, 8 to 12 centimeters (cm) wide. In an example, a portion of first and second infant restraints 3, 4 that may cover an infant's forearm (e.g. wrist to elbow) may be, for example, approximately the width of an infant's forearm (e.g. 7 cm wide). In an example, opening 5 may be, for example, 4 to 6.5 cm wide. In an example, a narrowest portion of first and second infant restraints 3, 4 (e.g.at loose ends) may be, for example, 4 to 6.5 cm wide (e.g. approximately the same or narrower width as opening 5). In an example, first and second infant restraints 3, 4 may be implemented, for example, with a curvature from widest to narrowest portions, e.g., from a base where joined to first portion 1 to a location where first infant restraint 3 may be pulled through opening 5 for a plurality of infants (e.g. pre or post term infants of all sizes). In an example, a narrowest portion of first and second infant restraints 3, 4 may be, for example, straight, e.g., form a loose end through to where a curvature ends, e.g., a point expected to be pulled through opening 5 for first infant restraint 3 and from a loose end to an equivalent point on second infant restraint 4. In an example, a wide base of first and second infant restraints 3, 4 may have, for example, parallel edges from first portion 1 to a curvature or angle (e.g. beginning at, on or after an infant forearms) tapering to a minimum width. In an example, first and second infant restraints 3, 4 may be, for example, 35 to 40 (e.g. 37) cm long. Wider loose ends (e.g. that may be in contact with another material such as a barrier and/or substrate) may provide more restraining capability than narrower loose ends. In an example, loose ends of first and second infant restraints 3, 4 may taper wider (e.g. where wide loose ends may be rolled or folded to feed through opening 5).

Third infant restraint 22 may, for example, be continuous with first portion 1, attached to first portion 1, detachable or otherwise removable from first portion 1. Third infant restraint 22 may be single or multi-purpose, for example, as an infant restraint and/or a barrier restraint (as indicated by 26). Use of third infant restraint 22 as an infant restraint and/or barrier restraint may vary, for example, based on a size and position of an infant and barrier. While the example shape of third infant restraint 22 is shown with straight lines and rectangular shape, infant and barrier restraints may have any shape (e.g. curved) suitable to their singular or multiple utilities. Third infant restraint may be used, for example, during phototherapy (e.g. for infant restraint and/or covering eyes).

First, second and third barrier restraints 24, 25, 26 may, for example, be continuous with first portion 1, attached to first portion 1, detachable or otherwise removable from first portion 1. A portion of positioning device 17 may be used as first, second and third barrier restraints 24, 25, 26. The portion(s) may vary, for example, based on infant size, infant position, barrier type, barrier size and/or barrier position. Barrier restraints may comprise one or more materials. In an example, all or a portion of a barrier restraint may comprise, for example, a (e.g. high) friction or grip material that increases friction (e.g. providing greater resistant to movement) between a barrier restraint and one or more materials that a barrier restraint may be in contact with (e.g. a barrier and/or a substrate under the barrier restraint). Although the example shown in FIGS. 1A-1B show a straight shape for barrier restraints, other shapes may be implemented, e.g., tab or strap edges of any shape or contour (e.g. curved) for discrete restraint, which may be alternative to or combined with continuous restraint. First, second and third barrier restraints 24, 25, 26 may comprise one or more types of restraint, e.g., overlay and tuck under a barrier and/or attachment to a barrier, such as quiet Velcro, quiet snaps, embedded magnets, continuous or discrete cinches or clamps.

In an example, infant and barrier restraints may be configured to restrain an infant and barrier by a (e.g. gentle or partial) tuck under a barrier, for example, as opposed to tucking an entirety of an infant or barrier restraint. A gentle or partial tuck may, for example, minimize disruption of an infant.

Second portion 2 may be joined or connected to portion 1, for example, by continuous material or attached material (e.g. stitched to first portion 1). Second portion 1 may be joined to portion 2, for example, by connection 34. A width of connection 34 may be equal to, greater than or less than a width of portion 1 and/or a width of portion 2. In an example (e.g. as shown in FIG. 1A), a width of connection 34 may be less than the width of first and/or second portions 1, 2. In an example, first portion 1 may be joined to first portion 2, for example, by a section of material (e.g. connection 34) having a width greater than an expected width of an (e.g. average) infant's hips and less than an expected width of a formed barrier (e.g. measured from center to center of the sides of a barrier). This may, for example, permit a positioning device to be tucked under more of a formed barrier without bunching, may permit a tighter compartment or wrap for an infant's legs (e.g. avoiding a large side-to-side gap) and/or may permit additional positions, such as one or more legs protruding through, e.g., protruding through a positioning device and over a formed barrier. Second portion 2 may comprise one or more infant restraints. In an example, portion 2 may be joined to connection 34 at angles (e.g. as shown by example in FIGS. 1A, 1B). In an example, a width of second portion 2 may be the same as, less than or greater than a width of first portion 1. Second portion 2 may comprise one or more infant restraints, one or more barrier restraints and zero or more accessory restraints. In an example, portion 2 may comprise one or more infant restraints, e.g., fourth infant restraint 23, and fourth and fifth barrier restraints 27, 28.

Fourth infant restraint 23 may, for example, be continuous with second portion 2, attached to second portion 2, detachable or otherwise removable from second portion 2. Fourth infant restraint 23 may be single or multi-purpose. Fourth infant restraint 23 may, for example, position and restrain all or a portion of an infant's lower body, e.g., one or more legs, knees, feet. Use of fourth infant restraint 23 as an infant restraint and/or barrier restraint may vary, for example, based on a size and position of an infant and barrier. While the example shape of third infant restraint 22 and/or barrier restraint 26 is/are shown with straight lines and rectangular shape, infant and barrier restraints may have any shape (e.g. straight, curved) suitable to their singular or multiple utilities. In an example, second portion 2 or fourth infant restraint 23 may comprise a flap. The flap may be applied, for example, to approximately an infant's knees, providing visualization of an infant's chest and abdomen.

One or more infant restraints may provide recoil upon an infant pushing out (e.g. kicking) while continuing to confine the infant in position (e.g. mimicking a womb). In an example, all or a portion of one or more infant restraints may comprise one or more layers of stretchable (e.g. elastic) material to provide desirable recoil. In an example, outer layers of a restraint (e.g. that may be in contact with an infant) may be uniform (e.g. stretchable) material. Reinforcing material 35 may, for example, be located between layers of stretchable material comprising second infant restraint 4 (e.g. with all or a majority of stitching on side that does not touch infant). In an example (e.g. as shown in FIG. 1A), first infant restraint 3 may comprise first elastic material 19, second infant restraint 4 may comprise second elastic material 20 and fourth infant restraint 23 may comprise third elastic material 21. First and/or second elastic material 19 and 20 may provide recoil for an infant's arm movements. Third elastic material 21 may provide recoil for an infant's leg movements. First, second and third elastic material 19, 20, 21 may have any dimension and position.

Fourth and fifth barrier restraints 27, 28 may, for example, overlap with portions of fourth infant restraint 23. Fourth and fifth barrier restraints 27, 28 may, for example, be continuous with second portion 2, attached to second portion 2, detachable or otherwise removable from second portion 2. A portion of positioning device 17 may be used as fourth and fifth barrier restraints 27, 28. Portion(s) utilized for restraint may vary, for example, based on infant size, infant position, barrier type, barrier size and/or barrier position. Barrier restraints may comprise one or more materials. In an example, all or a portion of a barrier restraint may comprise a high friction or grip material that increases friction between a barrier restraint and one or more materials that a barrier restraint may be in contact with (e.g. a barrier and/or a substrate under the barrier restraint). Although the examples in FIGS. 1A-1B show a straight shape for barrier restraints, other shapes may be implemented, e.g., tab or strap edges for discrete restraint, which may be alternative to or combined with continuous restraint. Fourth and fifth barrier restraints 27, 28 may comprise one or more types of restraint, e.g., overlay and tuck under a barrier and/or attachment to a barrier, such as quiet Velcro, quiet snaps, embedded magnets, continuous or discrete cinches or clamps.

A positioning device may be adaptable to a variety of surfaces or substrates, infants and positions and may be used to restrain one or more devices (e.g. comfort and/or medical devices). Accessories (e.g. inserts and/or attachments such as comfort or position-sculpting pads) may be permanently or removably attached inside and/or to one or more sides of (e.g. under, over) an infant positioning device. In an example, an infant positioning device may be provided with one or more interior and/or exterior pockets or attachment points (e.g. loops or slits) on one or more sides of the positioning device to secure one or more removable accessories for adaptation to infant size, position, barrier height and/or substrate. A type of restraint may be selected, for example, to minimize disruption of an infant during insertion and removal. In an example, an accessory restraint may comprise a pocket (e.g. open or closable). Multiple restraints may be implemented, for example, as a pocket on or in another pocket, which may support form-fitting, position sculpting and/or adaptation to substrates. In an example, a positioning device may accommodate a variety of accessory types, shapes and thicknesses. Accessory restraints may be implemented on multiple sides of a positioning device to permit variable shapes and depths, for example, to accommodate a wide variety of positions, infants and/or substrates. Accessories may be restrained for example, by compression, friction, closable pouches, sleeves, pockets, attachment or tether points, loops, slits or openings, zippers, quiet Velcro, quiet snaps and/or any other type of attachment. Accessory restraint material may be selected, for example for friction and/or compression fit. Accessory restraints may accommodate one or more thicknesses of accessories, e.g., to adapt to infants of many sizes.

Accessory restraints may support, for example, substrate adaptation, height adjustment, reliable position-sculpting, comfort pads or devices, medical devices, etc., without using unreliable, ad hoc devices that fall away over time. First, second, third and fourth accessory restraints 29, 30, 31, 32 may be used, for example, to restrain one or more accessories (e.g. substrate adaptation, comfort or position-shaping pads or pillows, comfort devices, medical devices). First, second, third and fourth accessory restraints 29, 30, 31, 32 may not be drawn to scale and may vary in number, size, dimensions, location, attachment technique, etc. among many different implementations. A positioning device may have zero or more accessory restraints. First, second, third and fourth accessory restraints 29, 30, 31, 32 may, for example, be continuous with first portion 1, attached to first portion 1, detachable or otherwise removable from first portion 1. Accessory restraints may be single- or multi-purpose. Accessory restraints may be positioned anywhere on positioning device 17. In an example, e.g., as shown in FIGS. 1A and 1B, restraints 29 and 30 are on a first (e.g. front) side of positioning device 17 and restraints 31, 32 are on a second (e.g. back) side of positioning device 17. Restraints 29, 30, 31, 32 may support one or more types of accessories, which may be used, for example, to adapt positioning device 17 to one or more substrates or surfaces, to one or more infant positions and/or to provide additional form fitting, comfort and/or medical treatment to infants of many sizes. Accessory restraints may be permanently and/or removably attached to positioning device 17 at one or more locations on one or more sides, e.g., to remain fixed in place or move. In an example, restraint 30 may be attached on one side (e.g. top side 33) or at one or more points, for example, to permit an accessory (e.g. position-sculpting pad) restrained by restraint 30 to move, rotate, pivot, flip or otherwise be moved to multiple positions, e.g., in a first location (e.g. between an infant's legs to promote proper hip development) in a first infant position (e.g. side-lying position) and in a second location (e.g. under an infant from head to umbilicus) in a second position (e.g. prone position). Restraint 30 may be removed or left unutilized in one or more infant positions. Restraint 31 may restrain an accessory, for example, to adapt infant positioning device 17 to a variety of surfaces. Restraint 31 may be unused, for example, when a substrate or surface under a positioning device is soft. Restraint 31 may be used, for example, when a substrate or surface under a positioning device is hard. Accessory type or thickness (e.g. body pad) may adapt to a variety of types of substrates or surfaces. Restraints 30 and 31 may, for example, oppose one another (e.g. on opposing sides of positioning device 17) and/or be stacked (e.g. on a same side), which may be used to add multiple accessories to provide an expanded range of depth for accessories for particular infants and/or positions. One or more accessory restraints may, for example, restrain one or more comfort or medical devices (e.g. sensors or monitors). Accessory restraints may be integrated into a positioning device and may be fixed or removable. In an example, an accessory restraint (e.g. and one or more portions of a positioning device in proximity to an accessory restraint) may be configured, for example, to not disturb an infant or interfere with positioning). In an example, a positioning device with and without an integrated or detachable accessory restraint may feel smooth (e.g. without feeling ridges or slopes), for example, by blending an accessory restraint with surrounding portions of a positioning device.

FIG. 1C is a side view of an example of an infant positioning device. FIG. 1C shows an example of accessories 11, 12, 13, 14 restrained by first, second, third and fourth accessory restraints 29, 30, 31, 32. An accessory may comprise anything that may (e.g. need to) be placed in close proximity to an infant, e.g., adaptive comfort or position-shaping pads or pillows, comfort devices, medical devices. An accessory may have any three-dimensional (3D) shape, e.g., flat, spherical, spheroid, cubical, cuboid, cylindrical, prismatic, conic, pyramidal. An accessory (e.g. functioning as a pad, pillow, position-sculpting) may comprise any suitable fill material (e.g. gel, fiber) and any suitable casing, cover or shaping material. An accessory (e.g. pillow) may have fill and/or wrap materials that help keep the shape of volume in one or more positions (e.g. the center of a pillow) and resist squishing into an unwanted shape, for example, when an infant's weight is applied to the accessory. In an example, a wrap material and/or accessory restraint may be less pliable than fill material and/or vice versa to maintain shape. One or more accessories may (e.g. also) be confined within a restrained barrier. In an example, (e.g. as shown in FIG. 1C), an accessory (e.g. 11, 12, 13 and/or 14) may comprise, for example, a gel pad/pillow with moldable gel filling in a container, which may be surrounded (e.g. partially or fully) by a cover. An accessory container and/or cover may have a shape, material and/or features configured to be restrained by one or more accessory restraints on or in a positioning device. In an example, an accessory container and/or cover may comprise a high friction material, e.g., to avoid sliding out of a sleeve or pouch-type of accessory restraint.

Although the example shown in FIG. 1C shows four cuboid-shaped pad-type accessories 11, 12, 13, 14 simultaneously inserted in four accessory restraints 29, 30, 31, 32, any number of accessories of any type, shape, etc. may be inserted in any number and type of accessory restraints in any number of positions. In an example (e.g. as previously mentioned), one or more accessory restraints (e.g. accessory restraint 30) may be attached on one side or at one or more points (e.g. attachment point(s) 33), for example, to permit a restraint and/or restrained accessory (e.g. accessory 12) to move, rotate, pivot, flip or otherwise be moved to multiple positions, e.g., in a first location (e.g. between an infant's legs to promote proper hip development) in a first infant position (e.g. side-lying position) and in a second position (e.g. under an infant from head to umbilicus) in a second position (e.g. prone position).

FIG. 2A is an example of a formable barrier that may be restrained by an infant positioning device. FIG. 2B is an example of a formable barrier that may be restrained by an infant positioning device. FIGS. 2A and 2B show two of many examples of forming one or more barriers independent of a positioning device e.g., to adapt to a term or pre-term infant of any size in any position. In an example, one or more formable barriers may be formed (e.g. into I, L, U or O shapes) to provide a partial or full boundary or containment. In an example (e.g. as shown in FIGS. 2A and 2B), a formable barrier (e.g. formable barrier 10) may be formed into a U-shape (e.g. FIG. 2A) or an O shape (e.g. FIG. 2B) around an infant. Formable barrier 10 may comprise, for example, core 7, filling 9, exterior material 6 and cover 8.

A barrier may have a variety of shapes, dimensions, weights, materials and flexibility. A barrier may comprise one or more materials in one or more layers. One or more layers may be formed material (e.g. foam, fabric, rubber, metal), loose material (e.g. sand, foam pellets, fabric pieces contained by another layer, casing or container) and/or liquid (e.g. gel). In an example, core 7 may comprise a material that resists changing shape or, in other words, holds a shape (e.g. metal rod or wire(s)). In an example, filling 9 may comprise foam or cotton filling. An exposed (e.g. outer) layer of a barrier may comprise one or more materials. One or more layers may be textured. In an example, exterior material 6 may comprise a cleanable material. In an example, exterior material 6 may comprise a high friction or grip material that increases friction between exterior material 6 and one or more materials that a barrier may be in contact with (e.g. a barrier restraint portion of an infant positioning device and/or a substrate under the barrier restraint). In an example, cover 8 may comprise a washable material and/or a high friction material relative to a substrate material under a barrier and/or an infant positioning device material. In an example, a formable barrier may comprise a rolled material (e.g. sheet, blanket) with or without a core or fasteners to maintain a rolled shape. In an example, a formable barrier may comprise a gel tube. A formable barrier may be weighted, for example, centrally and/or on one or more sides (e.g. weighted bottom or base).

A formable barrier may have any formable shape. Formable barrier 10 may be, for example, elongated or tubular. A formable barrier may comprise one or more portions that may be formable and one or more portions that may be fixed, rigid or unformable. A formable barrier may comprise one or more formable barriers. A formable barrier may have any cross section shape, e.g., curved (e.g. round, oval), rounded on one or more sides, flattened on one more sides, one or more sides longer or taller than one or more other sides, regular polygon (e.g. triangle, rectangle, square, octogon), irregular polygon. In an example, a base or lower section of a formable barrier may be wider than an upper or top section of the formable barrier.

A height of a barrier may be selected, for example, to serve a range of sizes for a type of infant (e.g. pre-term infant, term infant), a weight range for infants, a specific infant, etc. A relative height of an infant and barrier may be adjusted, for example, with one or more accessory pads. A length of a barrier may, for example, be long enough to wrap completely around infants of many different sizes, e.g., to form an O-shape in a developmentally supportive position.

Infant positioning may be implemented using one or more barriers and an infant positioning device arranged independent of the barrier(s). In an example, one or more (e.g. independently) formable barriers may be formed to provide a partial or full border, boundary or containment (e.g. a perimeter around an infant) based on, for example, a size and/or a desired position of an infant. A barrier restraint may be independently positioned to overlay and tuck under the barrier and underlay an infant of any size with one or more infant restraints over the infant and tucked under the barrier to provide reliable containment in any position. Independent arrangement of barrier(s) and an infant positioning device supports form-fitting adaptation to infants of all sizes that avoids using unreliable gap fillers that fall away over time.

FIG. 3A is an example of a positioning device and an infant barrier. In an example of an infant positioning system 18 (e.g. as shown in FIG. 3A), barrier 10 may be arranged in a U-shape, for example, based on a size and/or position of an infant to be restrained. Adapting barrier 10 to infant size and/or position may, for example, be based on an infant's bottom fitting in a bottom of a curved U-shape with interior sides of the U-shape snug on an infant's sides. Positioning device 17 may be laid over barrier 10, for example, when barrier 10 is in an estimated position for an expected infant and position. In an example, positioning device 17 may be , for example, wide enough to restrain barrier 10 with an infant centered and offset (e.g. following logroll) relative to positioning device 17 and may be long enough to restrain barrier 10 with infant centered and offset on positioning device 17. One or more accessories (e.g. substrate adaptation pads, position-sculpting pads, comfort and/or medical devices) may be adjusted, removed from, installed or attached to positioning device 17 (e.g. first, second, third and/or fourth accessory restraints 29, 30, 31, 32) before and/or after overlaying positioning device 17. In an example, one or more pads may be inserted/attached or removed to adapt to a substrate or for comfort, for height adjustment of an infant relative to the height of barrier 10 and/or for position-sculpting. One or more barrier restraints of positioning device 17 (e.g. first and second barrier restraints 24, 25 of first portion 1) may (e.g. preliminarily) restrain one or more portions of barrier 10, for example, by tucking under barrier 10, e.g., before an infant is placed on positioning device 17. Various implementations of infant positioning system 18 may be implemented with unrestrained and/or restrained accessories. Positioning device 17 may or may not have accessory restraints. Accessories may be implemented with their own restraints (e.g. with one or more restraints that may restrain an accessory, for example, by going under a barrier, going over and tucking under a barrier, friction with barrier, substrate and/or positioning device).

Adjustments may be made to barrier 10 and/or positioning device 17 (e.g. to form-fit to an infant's size and/or position), for example, before, during and/or after an infant is positioned on positioning device 17. One or more accessories may be adjusted, removed from, installed or attached to positioning device 17 before, during and/or after form-fitting of barrier 10 and/or positioning device 17. One or more accessory restraints, barrier restraints and/or infant restraints of positioning device 17 may be adjusted before, during and/or after any form-fitting modifications of barrier 10 and positioning device 17.

Interlocking interaction of positioning device and form-fitting barrier may provide synergistic interlocking restraint, e.g., interlocked circumferential infant containment and restraint in multiple dimensions. Redirection of forces (e.g. kicking) away from (e.g. perpendicular to) restraint axis or axes (e.g. using directional stretch material) may (e.g. further) improve the reliability of containment and position maintenance. A positioning device may be implemented, for example, to be directional (e.g. unidirectional, bidirectional, omnidirectional) relative to an infant, for example, when implemented with or without directional stretch material.

FIG. 3B is an example of a positioning device restraining an infant barrier and an infant. FIG. 3B shows an infant placed over and on positioning device 17 between a U-shape formed by barrier 10 (e.g. as shown in FIG. 3A). In an example, the infant may be placed in a supine position (e.g. head and body are midline) with legs flexed (e.g. knees close to or touching abdomen) and arms flexed (e.g. hands near face and elbows close to or touching torso). An infant may be placed, for example, with shoulders near first and second infant restraints 3, 4. In an example, barrier 10 may be form-fitted around the infant, e.g., by forming barrier 10 around an infant's head to form an O-shape or “nest” around the infant (e.g. as shown by example in FIG. 3B). First infant restraint 3 may be crossed over the infant's flexed arms (e.g. shoulder, upper arm) and fed through opening 5 in second infant restraint 4. First and second infant restraints 3, 4 may be pulled (e.g. with appropriate tension) and tucked under barrier 10 along with first and second barrier restraints 24, 25 on first portion 1 of positioning device 17, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). Fourth infant restraint 23 may be folded (e.g. at connection 34) over the infant's flexed legs. Each side of fourth infant restraint 23 (e.g. coinciding with fourth and fifth barrier restraints 27, 28) may be pulled (e.g. with an appropriate tension) and may be tucked under barrier 10 along with fourth and fifth barrier restraints 27, 28, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). Third infant restraint 26 may be folded over the infant's forehead (e.g. and eyes). Each side of third infant restraint 26 (e.g. coinciding with first and second barrier restraints 24, 25) may be pulled (e.g. with an appropriate tension) and may be tucked under barrier 10 along with first and second barrier restraints 24, 25, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant).

In an example, a restrained position of an infant (e.g. in supine position shown by example in FIG. 3B) may be maintained while changing positions, for example, by log-rolling an infant from supine to a variation of side-lying and back to supine. Changing infant positions (e.g. by log rolling) with a positioning device independent of a barrier may be performed with minimal disruption of an infant (e.g. without handling the infant and/or without aural disruption). A barrier may be repositioned to form-fit an infant in one or more changed positions, accessories may be adjusted as needed (e.g. slipped in or out of compression sleeves) and the repositioned barrier and any new or repositioned accessories may be restrained by the positioning device. Log-rolling an infant may be accomplished, for example, by un-restraining/releasing an edge of a positioning device, grabbing and lifting the edge (e.g. pulling at upward angle) to cause an infant to log-roll onto his/her side or to any degree of rotation between supine and side-lying and vice versa, which may be accomplished without directly handling an infant to change positions. Positioning device may be re-restrained at any new position (e.g. by tucking under a barrier). Log-rolling in midline position without handling may avoid unnecessary stress and risks, particularly for very low or extremely low birthweight (VLBW or ELBW) infants.

A barrier may be re-positioned (e.g. as needed) to form-fit an infant in a new (e.g. log-rolled) position, for example, while simultaneously moving a barrier and tucking a positioning device or otherwise restraining positions of a barrier and infant.

In an example, a positioning device and/or a barrier may comprise two or more components. One or more positioning devices may, for example, restrain one or more portions of an infant, one or more barriers and, e.g., optionally, one or more accessories.

FIG. 3C shows a side view of an example of a positioning device restraining a barrier and an infant. In an example, a height of barrier 10 relative to a height of an infant (e.g. adjustable, for example, by one or more accessory pads and/or by resting an asymmetrical barrier on a different side or using a different barrier) may be, for example, equal to or (e.g. slightly) greater than an anteroposterior chest diameter of an infant. First infant restraint 3 may be crossed over the infant's shoulders and arms and fed through opening 5 in second infant restraint 4. First and second infant restraints 3, 4 may be pulled (e.g. with appropriate tension), wrapped over (e.g. around) the top and sides of barrier 10 and tucked under barrier 10 along with first and second barrier restraints 24, 25 on first portion 1 of positioning device 17, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). Portions of first portion 1 of positioning device 17 are shown tucked under barrier 10. Fourth infant restraint 23 may be folded (e.g. at connection 34) over the infant's feet, back of legs, bottom and back. Each side of fourth infant restraint 23 (e.g. coinciding with fourth and fifth barrier restraints 27, 28) may be pulled (e.g. with an appropriate tension), wrapped over (e.g. around) the top and sides of barrier 10 and tucked under barrier 10 along with fourth and fifth barrier restraints 27, 28, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). Portions of second portion 2 of positioning device 17 are shown tucked under barrier 10. Full positioning device 17 may not be shown for clarity.

Wrapped and tucked (e.g. or otherwise held, attached, restrained) portions of positioning device 17 (e.g. first and second infant restraints 3, 4, first, second, fourth and fifth barrier restraints 24, 25, 27, 28) may help maintain barrier 10 close to an infant and maintain an infant in position, for example, without positioning device 17 or barrier 10 falling away over time. Independent positioning of barrier(s) 10 and positioning device(s) 17 with or without accessory restraints may support form-fitting adaptation to infants of many (e.g. all) sizes in many (e.g. all) positions. Independent adaptation may support developmentally accurate positioning from head to toe (e.g. leg adduction, trunk alignment, forward tilting pelvis, rounded back and shoulders, weight distribution, permitting hand to mouth movements and kicking with resistance back to flexion) and may avoid size gap fitting problems and corrective repositioning problems.

FIG. 4A is an example of a positioning device and an infant barrier, an accessory and an infant to be restrained by the positioning device. In an example of an infant positioning system 18 (e.g. as shown in FIG. 4A), barrier 10 may be arranged in a U-shape, for example, based on a size and/or position of an infant to be restrained. Positioning device 17 may be laid over barrier 10, for example, when barrier 10 is in an estimated position for an expected infant and position. One or more accessories (e.g. substrate adaptation pads, position-sculpting pads, comfort and/or medical devices) may be adjusted, removed from, installed or attached to positioning device 17 (e.g. using first, second, third and/or fourth accessory restraints 29, 30, 31, 32). An accessory may be inserted/attached, for example, to adapt to a substrate or for comfort, for height adjustment of an infant relative to the height of barrier 10 and/or for position-sculpting. In an example, an accessory (e.g. fourth accessory 14) may comprise one or more accessories restrained on one or multiple sides of positioning device 17 (e.g. fourth accessory restraint 30), for example, for position sculpting the infant in a prone position. One or more barrier restraints of positioning device 17 (e.g. first and second barrier restraints 24, 25 of first portion 1) may (e.g. preliminarily) restrain one or more portions of barrier 10, for example, by tucking under barrier 10, e.g., prior to final positioning of an infant placed on positioning device 17.

In an example (e.g. as shown in FIG. 4A), an infant may be placed on positioning device 17 between U-shaped barrier 10 over an accessory device (e.g. fourth accessory 14) in a prone position (e.g. with head and body supported by position-sculpting accessory with gently rounded back and shoulders and gently turned head) with legs flexed (e.g. knees close to or touching abdomen) and arms flexed (e.g. hands near face, elbows close to or touching torso and forearms resting on positioning device 17), such that most infant weight may be on fourth accessory (e.g. gel pillow) 14 with little pressure on infant knees and shins.

FIG. 4B is a bottom view of an example of a positioning device restraining a barrier, an accessory and an infant. In an example, a height of barrier 10 relative to a height of an infant (e.g. adjustable, for example, by one or more accessory pads and/or by resting an asymmetrical barrier on a different side or using a different barrier) may be, for example, equal to or (e.g. slightly) greater than an anteroposterior chest diameter of an infant. First infant restraint 3 may be crossed over an infant and fed through opening 5 in second infant restraint 4. First and second infant restraints 3, 4 may be pulled (e.g. with appropriate tension), wrapped over (e.g. around) the top and sides of barrier 10 and tucked under barrier 10 along with first and second barrier restraints 24, 25 on first portion 1 of positioning device 17, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). Portions of first portion 1 of positioning device 17 are shown tucked under barrier 10. Fourth infant restraint 23 may be folded (e.g. at connection 34) over the infant's feet, back of legs, bottom and back. Each side of fourth infant restraint 23 (e.g. coinciding with fourth and fifth barrier restraints 27, 28) may be pulled (e.g. with an appropriate tension), wrapped over (e.g. around) the top and sides of barrier 10 and tucked under barrier 10 along with fourth and fifth barrier restraints 27, 28, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). Portions of second portion 2 of positioning device 17 are shown tucked under barrier 10.

Wrapped and tucked (e.g. or otherwise held, attached, restrained) portions of positioning device 17 (e.g. first and second infant restraints 3, 4, first, second, fourth and fifth barrier restraints 24, 25, 27, 28) may help maintain barrier 10 close to an infant and maintain an infant in position, for example, without positioning device 17 or barrier 10 falling away over time. Independent positioning of barrier(s) 10 and positioning device(s) 17 with or without accessory restraints may support form-fitting adaptation to infants of many (e.g. all) sizes in many (e.g. all) positions. Independent adaptation may support developmentally accurate positioning from head to toe (e.g. leg adduction, trunk alignment, forward tilting pelvis, rounded back and shoulders, weight distribution, permitting hand to mouth movements and kicking with resistance back to flexion) and may avoid size gap fitting problems and corrective repositioning problems.

FIG. 5A is a cross section view of an example of a positioning device restraining a barrier and an infant. FIG. 5A shows positioning device 17 overlaying and tucking under barrier 10 to restrain barrier 10 to restrain barrier 10 and under- and over-laying an infant and overlaying and tucking under barrier 10 to restrain an infant. Other barrier restraints and infant restraints may be implemented. In an example, barrier 10 may be restrained, for example, with one or more positioning device attachment points on one or more sides of barrier 10 (e.g. inside, outside, top, bottom). FIG. 5A shows an example of barrier 10A (e.g. barrier 10 in FIGS. 2A-B, 3A-B, 4A-C) having a rounded-edge rectangular cross-section. Barrier 10A may provide a variable height barrier. In an example, barrier 10A may be positioned (e.g. on a substrate) on a first side 15 resulting in a first (e.g. shorter) barrier height or on a second side 16 resulting in a second (e.g. taller) barrier height. Barrier 10A may be selectively positioned (on a substrate) on first side 15 or second side 16, for example, depending on the height of an infant. Barrier height relative to an infant may support one or more types of infant and/or barrier restraint, e.g., wrapping over an infant and over top of a barrier. Relative barrier height may have less impact on restraint, for example, when an infant and/or barrier restraint termination occurs inside an area defined by a barrier, e.g., as opposed to outside an area defined by a barrier.

FIG. 5B is a cross section view of an example of a positioning device restraining a barrier and an infant. FIG. 5B shows an example of barrier 10B (e.g. barrier 10 in FIGS. 2A-B, 3A-B, 4A-C) having a round cross-section.

Infant positioning may be implemented, at least in part, in the form of operation, procedures or methods. FIG. 6 is an example of an infant positioning procedure. Example procedure 600 comprises example steps 605-635. No order of steps is required unless expressly indicated or inherently required. There is no requirement that an implementation of subject matter described herein implement all of the operations illustrated in the example shown in FIG. 6. Other implementations may implement one or more of the example operations shown in FIG. 6 in any order with or without other operations. FIG. 6 is simply one of many possible examples of subject matter disclosed herein. Various implementations may implement fewer, more, the same or different steps.

In example step 605, an infant barrier may be arranged according to at least one of a size and a first position of an infant. For example, as shown and discussed with respect to FIGS. 2A-B, 3A-B, 4A-C, 5A-B, infant barrier(s) 10 may be arranged (e.g. formed) into a shape (e.g. L, U or O shape) with dimensions, for example, based on at least one of an infant's size and desired position, e.g., in preparation to restrain the infant in the desired position. In an example, positioning a barrier may depend on which portions of an infant may be restrained or left unrestrained, e.g., for a desired position, medical procedure(s) or medical device sensors (e.g. with wires or tubes) that may be attached to the infant.

In example step 610, an infant positioning device may be arranged independent of the arranging of the infant barrier. For example, as shown and discussed with respect to FIGS. 1A-C, 3A-B, 4A-C, 5A-B, infant positioning device(s) 17 may be arranged independent of infant barrier(s) 10, for example, in preparation to restrain the infant in the desired position. Arrangement of a positioning device relative to a barrier may, for example, be based on an infant size and/or position.

In example step 615, one or more accessories may be restrained by an infant positioning device. For example, as shown and discussed with respect to FIGS. 1A-C, 4A-B, 5A-B, first, second, third and fourth accessory restraints 29, 30, 31, 32 may restrain accessories 11, 12, 13, 14. Accessories may comprise, for example, comfort devices (e.g. sounds, warming), medical devices, substrate adaptation pads, height adjustment pads and/or position-sculpting pads. A positioning device may have any number and type of accessory restraints.

In example step 620, an infant may be restrained in a first position by an infant positioning device. For example, as shown and discussed with respect to FIGS. 1A-C, 3A-B, 4A-C, 5A-B, an infant may be placed over and on positioning device 17 a supine position (e.g. head and body midline) with legs flexed (e.g. knees close to or touching abdomen) and arms flexed (e.g. hands near face and elbows close to or touching torso). First infant restraint 3 may be crossed over the infant's flexed arms and fed through opening 5 in second infant restraint 4. First and second infant restraints 3, 4 may be pulled (e.g. with appropriate tension) and tucked under barrier 10 along with first and second barrier restraints 24, 25 on first portion 1 of positioning device 17, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). Fourth infant restraint 23 may be folded (e.g. at connection 34) over the infant's flexed legs. Each side of fourth infant restraint 23 (e.g. coinciding with fourth and fifth barrier restraints 27, 28) may be pulled (e.g. with an appropriate tension) and may be tucked under barrier 10 along with fourth and fifth barrier restraints 27, 28, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). Third infant restraint 26 may be folded over the infant's forehead. Each side of third infant restraint 26 (e.g. coinciding with first and second barrier restraints 24, 25) may be pulled (e.g. with an appropriate tension) and may be tucked under barrier 10 along with first and second barrier restraints 24, 25, for example, while pressing in on multiple sides of U-shaped barrier 10 (e.g. to maintain form-fitting snug containment of the infant). A positioning device may have any number and type of infant restraints.

In example step 625, an infant barrier may be restrained from movement by an infant positioning device. Before, during and/or after restraining an infant, an infant barrier may be adjusted, as needed, to form-fit an infant in a position. For example, as shown and discussed with respect to FIGS. 1A-C, 2A-B, 3A-B, 4A-C, 5A-B, barrier(s) 10 may be restrained by positioning device(s) 17. A positioning device may have any number and type of barrier restraints. Barriers may be configured for one or more types of restraint (e.g. overlay and tuck under a barrier, quiet Velcro, quiet snaps, embedded magnets, continuous or discrete cinches or clamps, feed-through loops or slits) at one or more locations (e.g. inside, outside, top side, bottom side), for example, to cooperate with one or more types of restraint that an infant positioning device may be configured with.

In example step 630, an infant may be repositioned from a first position to a second position, for example, by repositioning the infant barrier independent of the infant positioning device and/or vice versa. Repositioning may involve, for example, partial release of one or more restraints, handling or not handling an infant (e.g. log rolling an infant without handling), form-fitting an infant barrier to infant in second position (e.g. when there may be gaps) and re-restraining. For example, as shown and discussed with respect to FIGS. 1A-C, 2A-B, 3A-B, 4A-C, 5A-B, an infant may be repositioned from a supine position (e.g. shown by example in FIG. 3B) to a prone position (e.g. shown by example in FIG. 4A). Repositioning may involve, for example, releasing one or more infant restraints (e.g. 3, 4, 22, 23) and/or barrier restraints (e.g. 26, 27, 28), changing the shape of a barrier (e.g. from an O shape to a U shape), adding or removing one or more accessories (e.g. restraining position sculpting pad accessory 14 with accessory restraint 30) and re-restraining one or more infant restraints (e.g. 3, 4, 23) and/or barrier restraints (e.g. 27, 28).

In an example, log-rolling an infant may be accomplished, for example, by un-restraining/releasing an edge of a positioning device, grabbing and lifting the edge to cause an infant to log-roll onto his/her side or to any degree of rotation between supine and side-lying and vice versa, which may be accomplished without directly handling an infant to change positions. A barrier may be re-positioned as needed to form-fit an infant in a new (e.g. log-rolled) position, for example, while simultaneously moving a barrier and tucking a positioning device or otherwise restraining positions of a barrier and infant.

In example step 635, a procedure may be performed on a restrained infant (e.g. with minimal access and disruption). For example, as shown and discussed with respect to FIGS. 1A-C, 2A-B, 3A-B, 4A-C, 5A-B, infant positioning system 18 may support procedures, for example, with minimal disruption and access. Procedures may include, for example, changing diapers, attaching sensors, inserting tubes, taking vital signs, etc. Portions of an infant positioning device and/or barrier may be unrestrained as needed, e.g., to allow various portions of a barrier to separate from an infant while other portions maintain position, without disturbing the infant. Snug containment by a barrier and multiple restraints may maintain an infant in a neutral and head midline position, for example, even when multiple restraints are not in use during a procedure, assessment or care time.

In an example, an infant positioning device may be used during admissions. An infant may be placed directly on a positioning device (e.g. during admission), with or without using a barrier. An infant may be well contained, for example, during umbilical line placement or chest x-rays. One or more restraints (e.g. 3, 4, 23) may be used during procedures (e.g. PICC dressing change) while exposing one or more limbs. A barrier may be partially or completely removed without lifting or disturbing an infant and replaced after a procedure. Minimizing disruption avoids infant stress, which may affect physiologic stability (e.g. low oxygen or heart rate drop events). Minimizing stress also avoids agitation, which may be dangerous for an intubated infant by leading to accidental extubations. An infant may remain on a positioning device, allowing movement without grasping and handling.

In an example (e.g. during a procedure), an infant head may be restrained and/or the infant's eyes may be covered (e.g. by third infant restraint 22). In an example, infant restraint 22/barrier restraint 26 may be folded over infants head and/or eyes and barrier restraints 24, 25 may be tucked under respective sides of barrier 10. This may minimize stress (e.g. caused by bright lights) without interfering with access to the infant and without interfering with tubing (e.g. an endotracheal tube).

In an example (e.g. phototherapy) procedure, one or more (e.g. all) infant restraints main be removed. A form-fit (e.g. snug) barrier (e.g. restrained by positioning device) may provide containment of an infant without infant restraints (e.g. during phototherapy). Infant restraints may be used to varying degrees. Selectable levels of containment and restraint may be implemented for a variety of procedures, assessments and other care (e.g. partially folding back restraint 2 to allow exposure of skin above the feet to phototherapy and tucking restraints 27,28 around barrier). In an example, fourth infant restraint 23 may restrain an infant's legs or feet with legs flexed (e.g. while other restraints may be released) for upper body procedure, assessment or care time (e.g. to allow exposure of skin to phototherapy). First and second infant restraints 3, 4 may be utilized to provide restraint during a lower body procedure or care. In an example, first and second infant restraints 3,4 may be utilized to provide restraint while fourth infant restraint 23 (or second portion 2) may be released, for example, to allow for assessment or care time (e.g. diaper change). A procedure may involve removing a barrier in different locations around an infant. A barrier may be removed with minimal disruption of an infant. In an example, barrier 10 may be removed and one or more restraints (e.g. first and second infant restraints 3, 4) may be tucked under an infant for position restraint.

In example step 640, an infant may be picked up by picking up a positioning device selectively with and without an infant barrier. For example, as shown and discussed with respect to FIGS. 1A-C, 2A-B, 3A-B, 4A-C, 5A-B, an infant may be picked up, for example, by picking up infant positioning device 17 selectively with and without barrier 10. A person (e.g. nurse or parent) may, for example, release barrier restraints and pick up positioning device 17 without barrier 10 (e.g. by picking up on one or more edges of positioning device 17) or (e.g. alternatively) may slide hands or a flat device under barrier 10 and positioning device 17 to move or pick-up together. An infant positioning device 17 (e.g. holding an infant) may be returned to an original position (e.g. relative to barrier 10). Positioning device 17 may avoid disruptive handling such as grasping, (e.g. unevenly) lifting and sliding a blanket under an infant for transfer (e.g. during skin to skin time).

Positioning system 18 may be utilized to mimic womb containment, restraint, positioning, movement and feedback. An infant may be restrained (e.g. in supine and side-lying positions) with legs flexed (e.g. knees close to or touching abdomen), arms flexed (e.g. hands near face and elbows close to or touching body) and head and body midline. This position may be maintained, for example, when an infant is log-rolled from supine to a variation of side-lying and back to supine. An infant may be restrained (e.g. in prone position) with legs fully flexed (e.g. knees close to or touching abdomen), arms flexed (e.g. hands close to face and forearms resting on first portion 1 (e.g. with or without position sculpting accessory), head and torso may be supported by position-sculpting accessory with back, shoulders and neck gently rounded. Barrier 10 may be positioned close to an infant's sides, restrained by positioning device 17. A form or snug fit may provide midline support of an infant's head (e.g. preventing the head from falling to far to one side), adduction of legs, trunk alignment, full flexion with a forward tilting pelvis, rounded back and shoulders, distributed weight while encouraging hand to mouth movements and kicking with resistance back to flexion.

Advantages of the disclosed positioning system and various components therein will be apparent to those of ordinary skill familiar with positioning aids such as Snuggle Up® by Children's Medical Ventures Inc. and Dandle ROO by Dandle-LION Medical. Devices may be evaluated, for example, with respect to containment (e.g. to mimic womb, decrease stress, improve sleep, brain development and weight gain), flexion of arms (e.g. for comfort, decreased stress, encourage feeding readiness), flexion of legs (e.g. for proper hip development, comfort and decreased stress), kicking and recoil (e.g. for bone and muscle development), proper prone positioning (e.g. for muscle development, preventing arching or tight neck muscles, open airway, comfort and improved sleep), head midline (e.g. for golden hour requirements and prevention of scaphocephaly), minimizing disturbance of infants (e.g. by minimizing handling), admissions, log rolling (e.g. for minimal handling), phototherapy (e.g. providing containment during phototherapy and reducing agitation), PICC line placement, ease of use (e.g. to increase reliability and avoid errors, staff satisfaction), cost (e.g. for budgeting and inventory).

Problems with Snuggle Up include, for example, containment (e.g. straps don't go over shins and nothing around head), flexion of arms (e.g. requires padding around sides), flexion of legs (e.g. infant can kick over), kick/recoil (e.g. restricts kicking, lack of recoil, infant can kick over), prone (prone tool is flat so infant head is turned too far to the side), head midline (e.g. requires padding to keep midline), disturbing infant (highly disturbing due to significant handling), admissions (e.g. not suitable), log rolling (e.g. not supported; must grab infant and turn to side), phototherapy (e.g. nothing to keep arms close to body and can kick out), PICC line placement (e.g. lack of infant containment for this procedure) and ease of use (e.g. requires ad hoc and other items and lengthy tutorial to use).

Problems with Dandle ROO include, for example, prone position (e.g. prone tool is placed under Dandle ROO, which doesn't allow for well flexed legs), head midline (e.g. gaps require ad hoc padding either side of head to keep midline), disturbing infant (e.g. Velcro sticks and can startle infant), admissions (e.g. not supported), phototherapy (e.g. requires ad hoc padding for containment and to keep arms close to body with wraps open for phototherapy), ease of use (e.g. difficult to learn how to use) and cost (e.g. expensive).

In contrast, the disclosed positioning system excels in these categories, for example, containment (e.g. infant's arms, head and legs remain well contained), flexion of arms (e.g. infant upper body restraints adjust for flexion of arms), flexion of legs (e.g. infant lower body restraint adjust for flexion of legs), kicking and recoil (e.g. elastic or stretchy material provides kicking and recoil while maintaining position and flexion), prone position (e.g. restrained or unrestrained accessories provide position sculpting for prone positioning), head midline (e.g. barrier and barrier restraint maintain head midline), minimal disturbance (e.g. restraining and unrestraining may be accomplished with minimal tucking), admissions (e.g. supported), log rolling (e.g. supported without handling), phototherapy (e.g. containment is provided by restrained barrier or minimal infant restraint (e.g. feet), arms are held close to body), PICC line placement (e.g. supported, for example, by partial barrier removal without disturbing infant, containment maintained with limb out), ease of use (e.g. easy to use, minimal inventory) and cost (e.g. inexpensive manufacturing, washable).

Systems, methods and instrumentalities have been disclosed for adaptive infant positioning to reliably maintain an infant of any size in any position. An infant positioning device may comprise, for example, one or more barrier restraints and infant restraints with or without accessory restraints. A barrier may form-fit an infant in any position (e.g. without gap fillers). A barrier restraint may resist barrier movement, e.g., by underlaying an infant and overlaying and tucking under a barrier. An infant restraint may resist infant movement, e.g., by overlaying an infant and tucking under a barrier. An accessory restraint may restrain accessories, e.g., for substrate adaptation, height adjustment, position-sculpting, comfort pads or devices and/or medical devices. Adaptive infant positioning may reliably maintain infants in proper developmental positions, reduce repositioning corrections, simplify positioning and repositioning procedures, reduce positioning errors, reduce handling and aural disruptions, reduce supplemental devices and procedures and/or reduce inventory space and costs.

The disclosed technology has been described with respect to a non-limiting examples. It will be understood by those skilled in the relevant art(s) that the spirit and scope of the subject matter of the present application encompasses a wide variety of implementations, including various changes in form and details to disclosed examples. The scope of subject matter presented herein is not limited to the examples, features, steps, order or discussion presented herein. Various implementations of the subject matter may comprise any number of features or steps described herein in an order, combination and configuration using any modality with and without variation in form and details within the spirit and scope of the disclosed technology. The appended claims encompass examples and features described herein, modifications and variations thereto as well as additional examples and features that fall within the true spirit and scope of the disclosed subject matter. 

What is claimed:
 1. A device comprising: an infant positioning device configured to position, reposition and maintain a term or pre-term infant of any size in a plurality of positions, the infant positioning device comprising: a barrier restraint that resists movement of a barrier when the infant moves, the barrier being formable independent of the infant positioning device to fit a term or a pre-term infant of any size in a plurality of positions; and an infant restraint that restrains movement by the infant.
 2. The device of claim 1, wherein the barrier restraint comprises a pliable layer that (i) overlays and tucks under the barrier and (ii) underlays the infant, and wherein the infant restraint overlays the infant and tucks under the barrier.
 3. The device of claim 2, wherein the infant restraint comprises a plurality of upper body restraints attached to the barrier restraint and configured to restrain the infant by crossing over the infant and tucking under the barrier.
 4. The device of claim 3, wherein at least a first one of the plurality of upper body restraints is configured to be joined to at least a second one of the plurality of upper body restraints.
 5. The device of claim 4, wherein the first one of the plurality of upper body restraints comprises an opening to feed at least the second one of the plurality of upper body restraints through the opening to join the first and second straps together.
 6. The device of claim 3, wherein the infant restraint comprises a lower body restraint configured to restrain the infant by folding over at least one of the infant's legs or abdomen and tucking under the barrier.
 7. The device of claim 6, wherein the lower body restraint comprises a flap extending or attached to the barrier restraint by less than a width of the barrier restraint.
 8. The device of claim 3, wherein the infant restraint comprises a head restraint configured to restrain the infant by folding over the infant's head and tucking under the barrier.
 9. The device of claim 2, wherein at least a portion of the infant restraint comprises elastic material that simulates a womb by allowing the infant's limb to push out on the elastic material and rebound while remaining securely held in position by the infant restraint.
 10. The device of claim 2, wherein a tucked portion of at least one of the barrier restraint and the infant restraint comprises a friction or grip material that resists movement by causing friction with at least one of the barrier above the tucked portion and a material under the tucked portion.
 11. The device of claim 1, further comprising: the barrier, wherein the barrier comprises at least one of a flat base, a weighted base, a base wider than a top of the barrier, and a friction or grip base.
 12. The device of claim 1, the infant positioning device further comprising: an accessory restraint that resists movement of an accessory.
 13. A method comprising: arranging an infant barrier according to at least one of a size and a first position of an infant; arranging an infant positioning device independent of the arranging the infant barrier; restraining, by the infant positioning device, the infant in the first position; and restraining, by the infant positioning device, the infant barrier from movement.
 14. The method of claim 13, wherein the arranging of the infant barrier comprises: arranging the infant barrier to form fit the infant barrier to the infant's size and the first position.
 15. The method of claim 13, wherein the restraining of the infant comprises: placing the infant in the first position over the infant positioning device; and restraining the infant by crossing a first infant restraint attached to the infant positioning device over the infant and tucking the infant restraint under the infant barrier.
 16. The method of claim 15, further comprising: joining, to the first infant restraint, a second infant restraint attached to the infant positioning device.
 17. The method of claim 16, wherein the joining comprises: feeding the second infant restraint through an opening in the first infant restraint.
 18. The method of claim 15, wherein the restraining of the infant further comprises at least one of the following: restraining the infant by folding a lower body restraint over the infant's legs or abdomen and tucking a portion of the lower body restraint under the infant barrier; and restraining the infant by folding a head restraint over the infant's head and tucking a portion of the head restraint under the infant barrier.
 19. The method of claim 13, wherein the restraining of the infant barrier comprises: tucking at least a portion of the infant positioning device overlaying the infant barrier under the infant barrier.
 20. The method of claim 13, further comprising: repositioning the infant from the first position to a second position by at least one of: repositioning the infant barrier independent of the infant positioning device; and repositioning the infant positioning device independent of the infant barrier.
 21. The method of claim 20, wherein the repositioning of the infant from the first position to a second position comprises: moving the infant barrier to fit the infant in the second position; restraining, by the infant positioning device, the infant in the second position; and restraining, by the infant positioning device, the infant barrier from movement.
 22. The method of claim 20, wherein the repositioning of the infant from the first position to the second position comprises: causing the infant to move from the first position to the second position by moving the infant positioning device without handling the infant.
 23. The method of claim 13, further comprising: picking up the infant by picking up the infant positioning device selectively with and without the infant barrier.
 24. The method of claim 13, further comprising: restraining, by the infant positioning device, at least one accessory comprising at least one of a comfort accessory, a medical device accessory, a substrate adaptation accessory, a height adjustment accessory and a position-sculpting accessory.
 25. A system comprising: an infant barrier adaptable to form-fit a term or a pre-term infant of any size in a plurality of positions, the infant barrier being formable independent of an infant positioning device; an infant positioning device configured to position, reposition and maintain a term or pre-term infant of any size in a plurality of positions, the infant positioning device comprising: a barrier restraint that resists movement of the infant barrier when the infant moves; and an infant restraint that resists movement by the infant.
 26. The system of claim 25, the infant positioning device further comprising: an accessory restraint that restrains an accessory.
 27. The system of claim 26, further comprising: the accessory.
 28. The system of claim 26, wherein the accessory comprises: at least one of a comfort accessory, a medical device accessory, a substrate adaptation accessory, a height adjustment accessory and a position-sculpting accessory. 